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WO2003041484A2 - Appareil et procede de reparation d'une blessure de la moelle epiniere - Google Patents

Appareil et procede de reparation d'une blessure de la moelle epiniere Download PDF

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Publication number
WO2003041484A2
WO2003041484A2 PCT/US2002/036058 US0236058W WO03041484A2 WO 2003041484 A2 WO2003041484 A2 WO 2003041484A2 US 0236058 W US0236058 W US 0236058W WO 03041484 A2 WO03041484 A2 WO 03041484A2
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WO
WIPO (PCT)
Prior art keywords
current
repair
spinal
electrodes
site
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2002/036058
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English (en)
Other versions
WO2003041484A3 (fr
Inventor
Michael F. Zanakis
Philip A. Femano
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DynaMed Systems LLC
Original Assignee
DynaMed Systems LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by DynaMed Systems LLC filed Critical DynaMed Systems LLC
Priority to EP02780607A priority Critical patent/EP1453570A4/fr
Priority to AU2002343648A priority patent/AU2002343648B2/en
Priority to CA002466883A priority patent/CA2466883A1/fr
Priority to JP2003543385A priority patent/JP4387191B2/ja
Publication of WO2003041484A2 publication Critical patent/WO2003041484A2/fr
Publication of WO2003041484A3 publication Critical patent/WO2003041484A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes

Definitions

  • the present invention relates to an apparatus and method for repairing spinal cord injury, and specifically an apparatus and method for stimulating regeneration and repair of damaged spinal nervous tissue.
  • axons or nerve fibers of the spinal cord are interrupted, generally by mechanical forces. If the spinal cord is compressed, severed or contused, the axons may be physically or physiologically disintegrated, so that no conduction of neuroelectric impulses can occur along the affected axon's length. Eventually, large populations of axons, including their associated cell bodies, may die, causing massive loss in communication between the brain and the peripheral nerves, and resulting in varying degrees of paraplegia or quadriplegia.
  • extravertebral placement of the electrodes means that the anode and cathode are physically remote from the site of injury. As a result, more power is required to deliver the requisite current to the injury site, potentially resulting in toxic effects to surrounding tissues, such as muscle, nerves and blood vessels. It is understood that regeneration and repair of spinal axons is meaningless if the muscles to be controlled or their associated blood vessels and nerves are damaged as a result. [0006] Further, extravertebral placement of electrodes necessitates situating the electrodes lateral to the site of the spinal cord injury, rather than in line therewith, resulting in less than optimal directional axonal guidance by the cathodal current.
  • extravertebral placement of electrodes affects the extent to which the electrical flux lines generated by the electrodes deviate from the ideal, which itself is a major determinant in the quality of the electrical field established in the spinal cord.
  • the flux lines within the spinal cord can be distorted from ideal by each intervening tissue that has a resistivity/conductivity differing from that of the muscle.
  • the tissues that vary in these parameters and through which the current must pass, in the case of extravertebral placement of electrodes include bone, ligaments, fat, cerebrospinal fluid, and vasculature. These structures may act as additional resistance or current shunts that can serve to deviate the resulting electric field within the spinal cord from a nominal field.
  • Extravertebral field application is rendered significantly less reliable and thus less efficacious as the result of the difficulty in predicting the effects of the different resistivity/conductivity parameters of the intervening tissues.
  • the present invention provides an apparatus suited to intravertebral implantation at the site of spinal cord injury, that allows DC stimulation of the injury site sufficient to induce regeneration and repair of damaged axons, but at a current below the non-toxic level of 75 ⁇ A/cm 2 .
  • the present invention also provides a method for stimulating regeneration and repair of damaged spinal axons through intravertebral implantation of electrodes at the site of spinal cord injury, and subsequent DC stimulation at the injury site sufficient to induce regeneration and repair of the damaged axons, but at a current level below the level at which tissue toxicity occurs.
  • An aspect of the present invention includes at least two electrodes configured to be placed intravertebrally proximal to the site of spinal axon injury and deliver DC current thereto.
  • Each electrode includes an aggregate conductive electrode surface sufficiently large such that the current density from the electrode surface will induce axon regeneration and repair without damaging the surrounding tissue.
  • the aggregate electrode surface includes multiple conductive sub-surfaces. The conductive sub-surfaces are separated from each other by non-conducting septa to minimize the production and dissipate any toxic product developed as the result of the delivery of electric current.
  • Another aspect of the present invention includes placing the electrodes of the present invention intravertebrally proximal the site of spinal cord injury and applying DC current at a level sufficient to induce regeneration and repair of damaged spinal axons but less than the current level at which tissue toxicity occurs.
  • the current is applied for a duration sufficient to prevent significant die-back and thereby achieve net growth.
  • the electrodes are arrayed so as to encompass a cross-sectional area of the spinal cord , in the area of the spinal axon injury.
  • the electrodes are arrayed in a three- dimensional geometry, such as a triangle, surrounding the site of spinal axon injury.
  • the DC current is applied for sufficient duration to prevent significant die-back, ensuring that forward-direction axon regeneration and repair prevails over die- back.
  • Figure 1 depicts three preferred configurations for the aggregate conductive electrode surface of the apparatus of the present invention.
  • Figure 2 is a graph of the electrode current profile across a single conductive electrode surface as a function of the relative distance across a single conductive electrode surface for each configuration depicted in Figure 1.
  • Figure 3 depicts the electrode surface of the apparatus of the present invention, showing various patterns of separation between adjacent conductive subsurfaces on the conductive electrode surface.
  • Figure 4 is a graph of the relationship of toxic product concentration in the tissue as a function of the separation between adjacent conductive sub-surfaces on the conductive electrode surface.
  • the apparatus for stimulating regeneration and repair of damaged spinal nerves of the present invention includes at least two electrodes that are configured to be placed intravertebrally proximal the site of spinal axon injury and deliver DC current thereto.
  • the electrodes include an aggregate conductive electrode surface through which the DC current is delivered to the injury site.
  • the aggregate conductive electrode surface is sufficiently large so that the density of the delivered DC current can induce axon regeneration and repair without generating a significant amount of toxic product in surrounding tissues.
  • the aggregate conductive electrode surface 10 may include a single conductive surface 20 or multiple conductive sub-surfaces 30. Where multiple conductive sub-surfaces 30 are used, the result is a flattening of the trans- surface current gradient, or "skin effect," across each sub-surface. As shown in Fig. 2, the benefit is that regeneratively efficacious currents can be delivered to the injury site while minimizing the delivery of toxic peak currents.
  • the uppermost curve shows the "skin effect" for multiple conductive sub-surfaces.
  • the middle curve shows the "skin effect” for a small number of conductive sub-surfaces
  • the lowermost curve shows the "skin effect" for a single conductive sub-surface.
  • the aggregate electrode surface includes multiple conductive sub-surfaces 30, adjacent sub-surfaces 30 are separated by non-conducting septa 40, as shown in Fig. 3.
  • the left figure shows no septum between conductive surfaces.
  • the center figure shows a small septum between the adjacent conductive surfaces.
  • the right figure shows a large nonconductive septum between adjacent conductive subsurfaces.
  • the specific geometry of the non-conducting septa 40 relative to the conductive sub-surfaces 30 may vary as required to optimize the contribution of the septal effect.
  • interposing non-conducting septa 40 between adjacent sub-surfaces 30 reduces the concentration, in surrounding tissues, of any toxic product developing as a result of the delivery of electric current through the electrode, by virtue of the dissipation of the toxic product across the total area of the entire aggregate conductive electrode surface 10.
  • the aggregate electrode surface includes conductive surfaces, either a single conductive surface 20 or multiple conductive sub-surfaces 30, and non-conductive septa 40.
  • Fig. 4 shows the relationship between the dilution of toxic product and the size of the non-conductive septa.
  • the non-conducting septa 40 may constitute empty space between adjacent conductive sub-surfaces 30.
  • the apparatus of the present invention may also be arrayed for use in neural systems having multi-directional axonal elements.
  • the electrical field may be applied sequentially along the direction of each damaged axon population.
  • the location of stimulating electrodes can vary depending on the direction along which regeneration and repair is sought, so that discrete epidural multi-electrode surfaces can be used to stimulate axonal growth in a selective fashion. For example, it is known that dorsally-situated axons will regenerate rostrally, while corticspinal axons, situated laterally, will regenerate caudally.
  • an intravertebral panel comprising a plurality of electrodes encompassing the cross- sectional area of the spinal cord can selectively produce cathodally-directed current for longer periods of time over the axon tracts of interest.
  • electrodes may be configured in a three-dimensional geometry, such that the aggregate electrode stimulation through multiple electrodes can generate an effective electrical field along any desired vector.
  • the number of electrodes in a given paradigm, the specific geometric placement of the electrodes, and the aggregate use of a plurality of electrodes may vary according to the demands of the therapeutic challenge for which DC stimulation is being applied.
  • the electrodes as described are placed intravertebrally proximal to the site of spinal axon injury. Once the electrodes are so placed and properly arrayed, a DC current is delivered through the electrodes to the injury site, inducing regeneration and repair of spinal axons.
  • the current density of the delivered DC current is sufficient to induce axon regeneration and repair while avoiding tissue toxicity.
  • the current density at the electrode-tissue interface is less than 75 ⁇ A/cm 2 .
  • intravertebral stimulation As relatively high resistivity tissues such as bone and fat are located distal to the desired locus of electrical field regeneration and repair, in intravertebral stimulation the bone, fat and meninges serve as a natural physical guidance means to provide a directional path for axonal regeneration and repair.
  • intravertebral regeneration and repair may represent an improvement over nerve regeneration and repair systems in which a physical guidance system is actively employed.
  • intravertebral electrode placement allows the safe delivery of higher currents to the injury site, so that higher field strengths can be injected thereto. Since the electrodes are applied locally, the relative amount of current delivered can be low, relative to extravertebral electrodes, and yet may achieve field strengths higher than extravertebral electrodes can achieve.
  • the duration of electrical stimulation is sufficient to prevent significant "die-back" phenomenon, as explained by McCaig, in “Spinal Neurite Reabsorption and Regrowth in vitro Depend on the Polarity of an Applied Electric Field,” Development 100, 31-41 (1987), and which is incorporated herein by reference.
  • the optimal stimulation duration will depend upon the specific therapeutic application. The duration will be sufficient to ensure that the forward- direction regenerative axon growth prevails over the "die-back" effect.
  • DC stimulation of damaged spinal axons may be used as a stand-alone regenerative and repair therapy, or may be used as an adjunct to other therapies, whether presently available or to become available in the future.
  • Such therapies include, but are not limited to, pharmaceutical, genetically-engineered, biological, surgical, psycho- and physical therapies.
  • the electrode including the electrode surface, may be made from conventional materials.
  • the DC current may be generated from any conventional DC generator used in biotherapeutic applications.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Appareil servant à stimuler la régénération et la réparation de nerfs rachidiens lésés, qui comporte au moins deux électrodes placées de manière intravertébrale à proximité du site de la lésion des axones et qui est destiné à appliquer un courant continu sur ce site. La présente invention concerne également un procédé destiné à stimuler la régénération et la réparation de tissus médullaires lésés, qui consiste à placer des électrodes de manière intravertébrale à proximité du site de lésion médullaire et à appliquer un courant continu à un niveau suffisant pour induire la régénération et la réparation des axones, mais à un niveau inférieur au niveau de courant toxique pour les tissus.
PCT/US2002/036058 2001-11-13 2002-11-12 Appareil et procede de reparation d'une blessure de la moelle epiniere Ceased WO2003041484A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP02780607A EP1453570A4 (fr) 2001-11-13 2002-11-12 Appareil et procede de reparation d'une blessure de la moelle epiniere
AU2002343648A AU2002343648B2 (en) 2001-11-13 2002-11-12 Apparatus and method for repair of spinal cord injury
CA002466883A CA2466883A1 (fr) 2001-11-13 2002-11-12 Appareil et procede de reparation d'une blessure de la moelle epiniere
JP2003543385A JP4387191B2 (ja) 2001-11-13 2002-11-12 脊髄損傷の修復のための装置および方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US35049001P 2001-11-13 2001-11-13
US60/350,490 2001-11-13

Publications (2)

Publication Number Publication Date
WO2003041484A2 true WO2003041484A2 (fr) 2003-05-22
WO2003041484A3 WO2003041484A3 (fr) 2003-07-03

Family

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Family Applications (1)

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PCT/US2002/036058 Ceased WO2003041484A2 (fr) 2001-11-13 2002-11-12 Appareil et procede de reparation d'une blessure de la moelle epiniere

Country Status (6)

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US (1) US6975907B2 (fr)
EP (1) EP1453570A4 (fr)
JP (1) JP4387191B2 (fr)
AU (1) AU2002343648B2 (fr)
CA (1) CA2466883A1 (fr)
WO (1) WO2003041484A2 (fr)

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WO2005092436A1 (fr) * 2004-03-19 2005-10-06 Medtronic, Inc. Procede et appareil destines a administrer des formes d'ondes de defibrillation multidirectionnelle
US7147647B2 (en) 2002-04-26 2006-12-12 Medtronic, Inc. Sintered titanium tube for the management of spinal cord injury
JP2007521925A (ja) * 2004-02-10 2007-08-09 スパイナル・エレメンツ・インコーポレーテッド 神経血管構造を保護するためのシステムおよび方法

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US20060167527A1 (en) * 2001-11-13 2006-07-27 Femano Philip A Apparatus and method for repair of spinal cord injury
AU2006306529A1 (en) * 2005-10-21 2007-05-03 Purdue Research Foundation Telemetrically controllable system for treatment of nervous system injury
US9101769B2 (en) 2011-01-03 2015-08-11 The Regents Of The University Of California High density epidural stimulation for facilitation of locomotion, posture, voluntary movement, and recovery of autonomic, sexual, vasomotor, and cognitive function after neurological injury
AU2012207115B2 (en) 2011-01-21 2016-03-10 California Institute Of Technology A parylene-based microelectrode array implant for spinal cord stimulation
MX344095B (es) 2011-03-24 2016-12-05 Univ Louisville Res Found Inc Neuroestimulador.
AU2012334926B2 (en) 2011-11-11 2017-07-13 The Regents Of The University Of California Transcutaneous spinal cord stimulation: noninvasive tool for activation of locomotor circuitry
CN106913955B (zh) 2011-11-11 2019-09-17 神经赋能科技公司 非侵入神经调节系统
US10092750B2 (en) 2011-11-11 2018-10-09 Neuroenabling Technologies, Inc. Transcutaneous neuromodulation system and methods of using same
AU2013274091B2 (en) 2012-06-15 2017-01-12 Case Western Reserve University Therapy delivery devices and methods for non-damaging neural tissue conduction block
US10195434B2 (en) 2012-06-15 2019-02-05 Case Western Reserve University Treatment of pain using electrical nerve conduction block
WO2014144785A1 (fr) 2013-03-15 2014-09-18 The Regents Of The University Of California Stimulation électrique transcutanée multi-site de la moelle épinière pour faciliter le déplacement
EP3782698A1 (fr) 2013-09-27 2021-02-24 The Regents Of The University Of California Relier des circuits de la moelle épinière cervicale pour permettre une nouvelle commande volontaire de la fonction de la main chez des sujets tétraplégiques
US20150217120A1 (en) 2014-01-13 2015-08-06 Mandheerej Nandra Neuromodulation systems and methods of using same
EP3183028A4 (fr) 2014-08-21 2018-05-02 The Regents of the University of California Régulation de commande autonome de vidange de la vessie après une lésion complète de la moelle épinière
EP3185946B1 (fr) 2014-08-27 2019-10-09 The Regents Of The University Of California Réseau à multiples électrodes pour stimulation épidurale de moelle épinière
US11298533B2 (en) 2015-08-26 2022-04-12 The Regents Of The University Of California Concerted use of noninvasive neuromodulation device with exoskeleton to enable voluntary movement and greater muscle activation when stepping in a chronically paralyzed subject
US11097122B2 (en) 2015-11-04 2021-08-24 The Regents Of The University Of California Magnetic stimulation of the spinal cord to restore control of bladder and/or bowel
US10864373B2 (en) 2015-12-15 2020-12-15 Case Western Reserve University Systems for treatment of a neurological disorder using electrical nerve conduction block
EP3582850B1 (fr) 2017-02-17 2024-06-12 The University of British Columbia Appareil de maintien des fonctions physiologiques
AU2018249498B2 (en) 2017-04-03 2023-12-14 Presidio Medical, Inc. Systems and methods for direct current nerve conduction block
WO2018217791A1 (fr) 2017-05-23 2018-11-29 The Regents Of The University Of California Accès aux réseaux spinaux dans le traitement de la dysfonction sexuelle
EP3974021B1 (fr) 2017-06-30 2023-06-14 ONWARD Medical N.V. Système de neuromodulation
US11992684B2 (en) 2017-12-05 2024-05-28 Ecole Polytechnique Federale De Lausanne (Epfl) System for planning and/or providing neuromodulation
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US12465260B2 (en) 2018-02-09 2025-11-11 Presidio Medical, Inc. Systems and methods for cardiac conduction block
US11813459B2 (en) 2018-02-20 2023-11-14 Presidio Medical, Inc. Methods and systems for nerve conduction block
WO2020010020A1 (fr) 2018-07-01 2020-01-09 Presidio Medical, Inc. Systèmes et procédés pour bloquer la conduction nerveuse
JP2021534877A (ja) 2018-08-23 2021-12-16 ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニアThe Regents Of The University Of California 神経根麻痺、馬尾症候群、及び上肢機能の回復のための非侵襲性脊髄刺激
EP3653260A1 (fr) 2018-11-13 2020-05-20 GTX medical B.V. Capteur dans des vêtements de membre ou une chaussure
DE18205821T1 (de) 2018-11-13 2020-12-24 Gtx Medical B.V. Steuerungssystem zur bewegungsrekonstruktion und/oder wiederherstellung für einen patienten
EP3695878B1 (fr) 2019-02-12 2023-04-19 ONWARD Medical N.V. Système de neuromodulation
CA3159295A1 (fr) 2019-11-24 2021-05-27 Douglas Michael Ackermann Polarisation de courant en tant que mecanisme de commande de fonctionnement d'electrode
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Cited By (6)

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Publication number Priority date Publication date Assignee Title
US7147647B2 (en) 2002-04-26 2006-12-12 Medtronic, Inc. Sintered titanium tube for the management of spinal cord injury
JP2007521925A (ja) * 2004-02-10 2007-08-09 スパイナル・エレメンツ・インコーポレーテッド 神経血管構造を保護するためのシステムおよび方法
US9072608B2 (en) 2004-02-10 2015-07-07 Spinal Elements, Inc. System and method for protecting neurovascular structures
US9693870B2 (en) 2004-02-10 2017-07-04 Spinal Elements, Inc. System and method for protecting neurovascular structures
US11554032B2 (en) 2004-02-10 2023-01-17 Spinal Elements, Inc. System and method for protecting neurovascular structures
WO2005092436A1 (fr) * 2004-03-19 2005-10-06 Medtronic, Inc. Procede et appareil destines a administrer des formes d'ondes de defibrillation multidirectionnelle

Also Published As

Publication number Publication date
JP2005508682A (ja) 2005-04-07
JP4387191B2 (ja) 2009-12-16
EP1453570A2 (fr) 2004-09-08
EP1453570A4 (fr) 2009-12-09
US20030105502A1 (en) 2003-06-05
AU2002343648B2 (en) 2006-05-25
WO2003041484A3 (fr) 2003-07-03
US6975907B2 (en) 2005-12-13
CA2466883A1 (fr) 2003-05-22

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